The Effects of EXOPULSE Mollii Suit on Low Back Pain

Last updated: November 20, 2024
Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

EXOPULSE MOLLII SUIT (active)

EXOPULSE MOLLII SUIT (sham)

Clinical Study ID

NCT06702189
2024-A00020-47
  • Ages 18-75
  • All Genders

Study Summary

Low back pain is a common musculoskeletal problem. It is the main cause of activity limitation and work absence and carries a huge medical burden and economic cost. Low back pain is considered "chronic" when it persists for more than 3 months. Chronic low back pain affects daily activities and constitutes a psychological burden, which could lead to anxiety and/or depression. Prevention of low back pain is recognized as a pivotal challenge in high-risk populations to help tackle high healthcare costs related to therapy and rehabilitation. Current pharmacological drugs, namely anti-inflammatory and narcotics medications, have limited efficacy and numerous side effects. In addition, most available treatment options only address single, targeted causes; however, given the complexity of low back pain, a multi-modal interdisciplinary approach is highly needed. Transcutaneous electrical nerve stimulation (TENS) is a safe alternative to current treatments. Many studies have shown its efficacy and benefit in reducing pain. However, it only targets a limited number of muscles. For this reason, transcutaneous stimulation using the EXOPULSE Mollii suit might help reduce pain and related outcomes in this context since it simultaneously targets several muscle groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged between 18 and 75 years, with a definite diagnosis of Low Back Painfor at least 3 months, with absence of any surgical indication.

  • Stable pharmacological treatment over the last three months

  • Residual back pain post-spinal surgery with no new surgical indication

  • Patients should be French speakers, able to understand verbal instructions, andaffiliated to the national health insurance NHI.

Exclusion

Exclusion Criteria:

  • Patient with VAS < 4

  • Presence of any surgical indication (i.e,. isthmic spondylolisthesis, herniateddisc, Spinal canal stenosis, Vertebral fracture, Degenerative Spondylolisthesis,scoliosis)

  • Failed Back Surgery Syndrome (FBSS)

  • Presence of spinal infection

  • Presence of obstetrical or gynecological cause of the low back pain (ovariantorsion, ovarian cyst, endometriosis, menses)

  • Retroperitoneal tumors - Spinal tumors - Being included in another research protocolduring the study period

  • Inability to undergo medical monitoring for the study purposes due to geographicalor social reasons

  • Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofenpump, or other contraindications to using EXOPULSE Mollii suit

  • Being pregnant

  • Having a change in their pharmacological therapy in the last three months.

  • Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias,uncontrolled epilepsy, diseases causing osteoarticular and muscular pain)

  • Having a body mass index above 35 Kg/m2

  • In case of the introduction of a medical device other than EXOPULSE Mollii suitduring the study period

  • Patients under juridical protection (" mesure de protection judiciaire : tutelle,curatelle, sauvegarde de justice ")

  • Prisoners

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: EXOPULSE MOLLII SUIT (active)
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Clinical Neurophysiology department, Henri Mondor Hospital, Créteil, France

    Créteil, Val de Marne 94000
    France

    Active - Recruiting

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